[pending] LANREOTIDE ACETATE (LANREOTIDE ACETATE)
Pending LLM rewrite. Source: FDA_DRUG D-0422-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
The recalled product
- Product
- LANREOTIDE ACETATE (LANREOTIDE ACETATE)
- Brand
- LANREOTIDE ACETATE
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot
- expiry: 4401666IR1
- Exp 8/31/2027
- 4401703IR1
- Exp 9/30/2027
- 4401703IR2
- EXP 9/30/2027
- 4401704IR1
- 4401705IR1
- 4401706IR1
- 4401720IR1
- 4401721IR1
- 4401733IR1
- 4401770IR1
- 4401777IR1
- 4401788IR1
- Exp 10/31/2027
- 4401804IR1
- 4401805IR1
- 4401824IR1
Distribution
Distributed nationwide across the United States.
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